New Regulations Mandate Institutional Review Board Registration

Posted

The Office for Human Research Protections (OHRP) has added a new subpart to the HHS protection of human subjects regulations requiring Institutional Review Boards to register with HHS.

The new regulation applies to IRBs that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federal-wide use by OHRP (see 74 FR 2399). Information to be registered includes contact information, number of active research protocols, and IRB staffing. A companion regulation was issued by the Food and Drug Administration requiring registration for IRBs reviewing clinical investigations involving FDA-regulated products (74 FR 2358). A single HHS registration system for both regulations will be accessible on the OHRP Web site. The two rules become effective July 14, 2009, and initial registration must be submitted by September 14, 2009. Please contact OHRP directly for additional information.